Active not recruitingEARLY_PHASE1INTERVENTIONAL

CAR T Therapy With GCAR1 for Relapsed Alveolar Soft Part Sarcoma

This study is exploring a new treatment called GCAR1 for a rare cancer known as alveolar soft part sarcoma (ASPS). ASPS often affects young adults and can be difficult to treat, especially if it returns after initial therapies. This particular study is for one patient whose ASPS has come back and isn't getting better with usual treatments. The GCAR1 treatment uses the patient's own immune cells, which are specially trained to find and fight cancer cells that have a specific marker called GPNMB. The main goal is to check if this treatment is safe and whether it can help the patient. It's an early-stage study, meaning researchers are still learning about how this treatment works.

At a glance

Status

Active not recruiting

Phase

EARLY_PHASE1

Sponsor

University of Calgary

Enrolment target

Start

30 Jan 2025

Estimated completion

30 Jan 2030

Sarcoma Alveolar Soft Part Sarcoma (ASPS)

What is this study about?

This study focuses on a special type of cancer called alveolar soft part sarcoma, or ASPS. It's quite rare, and sometimes it can return even after treatment. When ASPS comes back and standard treatments aren't working anymore, doctors look for new ways to help. This particular study is designed for a single patient with ASPS that has returned and is progressing, meaning it's getting worse.

The treatment being tested is called GCAR1. It's a type of 'cell therapy,' which means it uses cells from your own body. Specifically, some of your immune cells (a type of white blood cell) are taken out, specially modified in a lab, and then put back into your body. These modified cells are like tiny, smart soldiers – they're trained to recognise and attack ASPS cells that have a specific protein on their surface called GPNMB. The patient in this study has been treated with GCAR1 before, and doctors want to see if it can be helpful again.

The main purpose of this study is to see if GCAR1 is safe and if it can help stop the cancer from growing or even shrink it. Since this is an early-stage study, researchers are carefully watching for any side effects and how the treatment affects the cancer. It's important to remember that this is a very individualised treatment, tailored specifically for the patient. It offers a potential option when other treatments are no longer effective.

Key takeaways

Targets a rare cancer called ASPS that has relapsed.
Uses a special cell therapy (GCAR1) that trains your own immune cells to fight cancer.
An early-stage study, focused on safety and potential effectiveness.
Designed for a patient when other treatments are no longer an option.
Involves careful monitoring and regular check-ups.

Who may be eligible?

This study is for a specific patient. Generally, to be considered for a study like this, you would need to be able to give your informed consent, which means you fully understand the study and agree to take part. Your body's important organs, like your kidneys and heart, would need to be working well enough. For example, your kidney function would need to be above a certain level, and your heart's pumping ability would also be checked.

There are also reasons why someone might not be able to join. For instance, if you have an active infection that isn't being controlled, or if you are pregnant or breastfeeding, you wouldn't be able to take part. Also, if you've recently had other cancer treatments, there's usually a waiting period of at least three weeks before you could start this therapy. This allows your body to recover from any previous treatment effects.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you able to fully understand and agree to take part in the study?
Are your kidneys working reasonably well?
Is your heart working well enough?
Do you have any infections that are not under control?
Are you pregnant or currently breastfeeding?
Have you had other cancer treatments in the last three weeks?

Answer every question to see your result.

What does participation involve?

This study is designed for a single patient. Taking part would involve several steps. First, you would need to have some of your blood cells collected so they can be specially prepared in the lab to create the GCAR1 treatment. Before receiving the GCAR1 treatment, you would likely have a short course of chemotherapy to help prepare your body for the new cells. Then, the GCAR1 cells would be given back to you through an infusion, similar to a blood transfusion.

Throughout the study, you would have regular hospital visits and check-ups. These would involve blood tests, scans (like CT or MRI scans) to see how the cancer is responding, and close monitoring by the medical team to check for any side effects. The exact duration of your participation and follow-up would be discussed in detail by the study team.

Potential risks and benefits

Participating in a study like this could potentially offer a new treatment option when standard treatments are no longer working for your type of cancer. The potential benefit is that the GCAR1 therapy might help to control or shrink your cancer. However, as with any new treatment, there are potential risks and side effects, some of which could be serious. The medical team will carefully explain all known and potential risks before you decide to take part. You will also be closely monitored throughout the study to manage any side effects. It's very important to remember that you have the right to withdraw from the study at any time, for any reason, without affecting your future medical care.

Locations (1)

Arthur J.E. Child Comprehensive Cancer Centre
Verified postcode
Calgary, Canada

Common questions

What is alveolar soft part sarcoma (ASPS)?

ASPS is a rare type of cancer that forms in soft tissues, like muscles. It's often found in places like the legs or arms.

What is GCAR1 treatment?

GCAR1 is a special cell therapy where your own immune cells are taken, trained in a lab to fight cancer, and then given back to you.

Why is this study for one patient?

This is an early-stage study for a very specific situation where a patient's cancer has returned and other treatments aren't available or working. It helps doctors learn more about the treatment in difficult cases.

Will I get chemotherapy with this treatment?

Yes, it's likely you would have a short course of chemotherapy before receiving the GCAR1 cells to help your body prepare for the treatment.

Can my cancer be cured with this treatment?

There are no standard cures for ASPS when it has returned. This study aims to see if GCAR1 can help control the cancer, but it's not known if it can provide a cure.